NCT06144814

A Comparison of Hyaluronic Acid and Estradiol Treatment in Vulvovaginal Atrophy.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Koru Health Groups · Academic / Other
• Sex: Female
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observational study isto compare the effect hyaluronic acid and estradiol in vulvo-vaginal atrophy.Hyaluronic acid and Estrogen were equally effective in vaginal treatment. Hyaluronic acid may be preferred for patients in whom hormonal therapy is contraindicated or who wish to receive non-hormonal therapy.

Detailed description

This randomized, controlled, monocentric, prospective, comparative (before/after) study was conducted at Koru Ankara Hospital between April 2023 and September 2023. Patients were randomized into 2 groups. A total of 300 patients, 150 in each group, were included in the study. Informed written consent was obtained from the volunteers who willingly participated in the study. Group I received 25 µg vaginal estrodiol (Vagifem®). 1 tablet a day for two weeks, then 2 times a week for the next 2 weeks. Group II received 5 mg of vaginal hyaluronic acid every day for 14 days, then 2 days a week for the next 2 weeks. Hyaluronic acid gel for vaginal use was supplied by ORTHOGEN®. The treatment period lasted 1 month in both groups. Before receiving treatment, patients who consented to participate in the study were examined by a Gynecologist, and Vaginal Health Index (VHI)12 score was determined. After the end of the treatment period, the patients were re-evaluated by the same physician, and the VHI score was obtained again. The VHI is the most common score based on vaginal elasticity, secretions, pH, presence of petechiae on the epithelial mucosa, and hydration assessment. The score can range from 5 to 25, and \<15 is considered an atrophic vagina index. Vaginal pH was measured by placing pH paper on the anterior wall of the vagina. A value \>5 pH was defined as decreased estrogen activity13. The effect on the primary outcome VHI index was investigated.

Conditions

• Vulvovaginal Atrophy

Interventions

Type	Name	Description
DRUG	Hyaluronic acid vaginal gel	. Group II received 5 mg of vaginal hyaluronic acid every day for 14 days, then 2 days a week for the next 2 weeks. Hyaluronic acid gel for vaginal use was supplied by ORTHOGEN®. The treatment period lasted 1 month in both groups.
DRUG	Estrogen vaginal use form	Group I received 25 µg vaginal estrodiol (Vagifem®). 1 tablet a day for two weeks, then 2 times a week for the next 2 weeks.

Timeline

• Start date: 2023-04-05
• Primary completion: 2023-09-15
• Completion: 2023-09-30
• First posted: 2023-11-22
• Last updated: 2023-11-22

Locations

1 site across 1 country: Turkey (Türkiye)